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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2018.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2018]
[CITE: 21CFR801.57]
See Related Information on Discontinuation of legacy FDA identification numbers assigned to devices. in CDRH databases



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES

PART 801 -- LABELING

Subpart B--Labeling Requirements for Unique Device Identification

Sec. 801.57 Discontinuation of legacy FDA identification numbers assigned to devices.

(a) On the date your device must bear a unique device identifier (UDI) on its label, any National Health-Related Item Code (NHRIC) or National Drug Code (NDC) number assigned to that device is rescinded, and you may no longer provide an NHRIC or NDC number on the label of your device or on any device package.

(b) If your device is not required to bear a UDI on its label, any NHRIC or NDC number assigned to that device is rescinded as of September 24, 2018, and beginning on that date, you may no longer provide an NHRIC or NDC number of the label of your device or on any device package.

(c) A labeler who has been assigned an FDA labeler code to facilitate use of NHRIC or NDC numbers may continue to use that labeler code under a system for the issuance of UDIs, provided that --

(1) Such use is consistent with the framework of the issuing agency that operates that system; and

(2) No later than September 24, 2014, the labeler submits, and obtains FDA approval of, a request for continued use of the assigned labeler code. A request for continued use of an assigned labeler code must be submitted by email to: GUDIDSupport@fda.hhs.gov, or by correspondence to: UDI Regulatory Policy Support, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3303, Silver Spring, MD 20993-0002.

(d) Each request for continued use of an assigned labeler code must provide--

(1) The name, mailing address, email address, and phone number of the labeler who is currently using the labeler code;

(2) The owner/operator account identification used by the labeler to submit registration and listing information using FDA's Unified Registration and Listing System (FURLS).

(3) The FDA labeler code that the labeler wants to continue using.

[78 FR 55820, Sept. 24, 2013, as amended at 81 FR 11428, Mar. 4, 2016]

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